Labor Market Info
Outreach & Teaching
Testing & Assessment
Trabaja en el Gobierno
Directorio del Servicio Nacional de Empleo
Working in Canada
Education & Training
Senior Manager, QA & Compliance
Assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines, and fulfill client and Covance requirements.
Assure that all projects for which Global QA Lead responsibilities have been assigned have an audit strategy agreed and documented in the QA&C central planning system.
Assist with the allocation of QA&C staff to complete the required audits.
Assure that audits as defined in the global audit plan are completed on time and within budget including reporting and follow up to closure.
Provide local leadership and line management as required.
Lead and participate in special projects.
Contribute to process improvement initiatives across organization.
Represent QA on project teams, management meetings, and other internal forums as well as client meetings and audits.
Participate in negotiations with clients.
Contribute to the preparation of Time and Cost Estimates as requested.
Role will require ~ 30% travel, primarily domestic but may include international as applicable
University/college degree, BA/BS (life science preferred) or equivalent experience.
Advanced degree (e.g. postgraduate qualification in quality assurance) or equivalent experience.
Strong analytical skills.
Knowledge, understanding and experience in applying ICH/FDA Good Clinical
Excellent oral, written and presentation skills.
Excellent planning and organizational skills.
Proven interpersonal skills.
Demonstrated ability to handle multiple competing priorities across clinical operating units.
Ability to inspire effective teamwork and motivate staff within a matrix system.
Ability to function as a member of a global clinical team.
Experience 4 Years experience in Clinical Quality Assurance, preferably with GCP experience.
7 Years experience in other professional roles within pharmaceutical/CRO environment.
Other required work-related experiences:
Proven ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process.
Financial understanding of global clinical development budgets.
Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
Knowledge of the drug development process from the perspective of a contract research organization.
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